The U.S. Food and Drug Administration has revoked a tentative approval for Ranbaxy Laboratories to make a cheap copy of AstraZeneca’s heartburn drug Nexium, after its Indian plants were banned over quality control issues.
The FDA has also stripped Ranbaxy of tentative approval and six-month exclusivity for a copy of Roche’s antiviral Valcyte, a fresh blow to the Indian company that has been hit by a raft of regulatory bans over poor production quality.
The U.S. regulator has banned all of Ranbaxy’s India-based plants under a wider scrutiny of the country’s $15 billion pharmaceutical industry, which is the largest supplier of generic medicines to the United States. Ranbaxy was the first company to receive tentative approvals to launch the cheaper copies of the two drugs in 2008, making it eligible to exclusively market the medicines for six months — a huge revenue generating opportunity.
The launch of Nexium and Valcyte generics had been awaiting final approval from the FDA. That was delayed as Ranbaxy struggled to resolve quality control issues at its drug manufacturing plants.
Ranbaxy said in a statement on Thursday that the FDA informed the company that the regulator’s original decisions granting tentative approval were “in error because of the compliance status of the facilities’’ mentioned in the applications. The FDA also told the Indian drugmaker there were no ‘data integrity issues’ related to the company’s filings for the two drugs, Ranbaxy said. The company did not elaborate and a spokesman did not respond to a mail seeking comment. “Ranbaxy is disappointed with this development and is actively evaluating all available options to preserve its rights,” the company said.
